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Terminated

Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.

FDA Recall Z-0860-2012 · Posted 2012-01-25

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2011-12-12
Date Terminated2014-01-14
Product Quantity1

Reason for Recall

Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.

Firm Action

Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit.

Root Cause

Process control

Distribution Pattern

Product distributed in one hospital in California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061054AXIOM ARISTOS FX PLUSSiemens Medical Solutions USA, Inc. · 2006-05-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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